Product Details for NDA 050749
OMNICEF (CEFDINIR)
125MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
250MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
125MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: CEFDINIR
Proprietary Name: OMNICEF
Dosage Form; Route of Administration: FOR SUSPENSION; ORAL
Strength: 125MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N050749
Product Number: 001
Approval Date: Dec 4, 1997
Applicant Holder Full Name: ABBVIE INC
Marketing Status: Discontinued
Patent and Exclusivity Information
OMNICEF (CEFDINIR)
Proprietary Name: OMNICEF
Dosage Form; Route of Administration: FOR SUSPENSION; ORAL
Strength: 125MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N050749
Product Number: 001
Approval Date: Dec 4, 1997
Applicant Holder Full Name: ABBVIE INC
Marketing Status: Discontinued
Patent and Exclusivity Information
250MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: CEFDINIR
Proprietary Name: OMNICEF
Dosage Form; Route of Administration: FOR SUSPENSION; ORAL
Strength: 250MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N050749
Product Number: 002
Approval Date: Jul 29, 2004
Applicant Holder Full Name: ABBVIE INC
Marketing Status: Discontinued
Patent and Exclusivity Information
Proprietary Name: OMNICEF
Dosage Form; Route of Administration: FOR SUSPENSION; ORAL
Strength: 250MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N050749
Product Number: 002
Approval Date: Jul 29, 2004
Applicant Holder Full Name: ABBVIE INC
Marketing Status: Discontinued
Patent and Exclusivity Information